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ALS Worldwide
February 16, 2016

MicroNeurotrophin Drug Development: Key Steps

Development (2005-2014)
FUNDED & COMPLETED
MicroNeurotrophin drugs were discovered and developed by Professor Achilleas Gravanis and his scientific colleagues at the University of Crete in Greece.

 

Preclinical ALS Research (January-October 2015)
FUNDED & COMPLETED
While in vivo (animal) or in vitro (cell culture) models remain challenging as a reliable method to predict a drug’s effectiveness for humans with disease like ALS, these FDA required tests by FDA have been completed.

Most importantly, in preclinical trials, MicroNeurotrophin drugs appear to protect and strengthen the nerve cells affected by ALS in both animal and cell models, without showing any signs of toxicity or harmful side effects.


KEY NEXT STEPS…

FDA Required Independent Safety Studies (2-3 months)
Cost: $1,875,000 – FUNDING REQUIRED
Before clinical trials may begin in humans, the FDA requires confirmation that the new drug is safe in animals. These expensive safety studies must be conducted by an independent FDA-approved Contract Research Organization (CRO) that follows strict guidelines to ensure the integrity of the safety tests on MicroNeurotrophins.

Phase 1 Investigational New Drug (IND) Trial (6 months)
Cost: $2,000,000 –
FUNDING REQUIRED

MicroNeurotrophin drugs will be produced and tested on a small group of 20 to 80 people for the first time to evaluate its safety. Researchers determine how best to administer the drugs to limit risks, maximize possible benefits, and identify side effects.

If proven safe in Phase I, MicroNeurotrophins will be tested for effectiveness in Phase II and Phase III, for which additional funding will be required.